Miljöpåverkan
Miljöinformationen för salicylsyra är framtagen av företaget MSD för Elosalic®, Momesalic
Miljörisk:
Användning av salicylsyra har bedömts medföra försumbar risk för miljöpåverkan.
Nedbrytning:
Salicylsyra bryts ned i miljön.
Bioackumulering:
Salicylsyra har låg potential att bioackumuleras.
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Detaljerad miljöinformation
Environmental Risk Classification
Predicted Environmental Concentration (PEC)
PEC is calculated according to the following formula:
PEC (μg/L) = (A*109*(100-R))/(365*P*V*D*100) = 1.5*10-6*A(100-R)
PEC = 0.02 μg/L
Where:
A = 122 kg (total sold amount API in Sweden year 2019, data from IQVIA) (Ref I.)
R = 0 % removal rate (worst case assumption)
P = number of inhabitants in Sweden = 9 *106
V (L/day) = volume of wastewater per capita and day = 200 (ECHA default) (Ref. II)
D = factor for dilution of waste water by surface water flow = 10 (ECHA default) (Ref. II)
Predicted No Effect Concentration (PNEC)
Ecotoxicological studies
Crustacean, water flea (Daphnia magna):
Acute toxicity
EC50 48 h = 870,000 μg/L (endpoint unknown; unknown method) (Ref. III)
Chronic toxicity
NOEC 21 d = 10,000 μg/L (endpoint unknown; OECD 202) (Ref. IV)
Fish (Pimephales promelas):
Acute toxicity
LC50 96 h = 1,380,000 μg/L (mortality; unknown method) (Ref. IV)
Algae (Scenedesmus subspicatus):
EC50 72 h (cell density) > 100,000 μg/L (OECD 201) (Ref. IV)
PNEC = 100 μg/L (10,000 μg/L/100 based on the most sensitive chronic NOEC for the daphnia with an assessment factor (AF) of 100)
Environmental risk classification (PEC/PNEC ratio)
PEC/PNEC = 0.02/100 = 0.0002, i.e. PEC/PNEC ≤ 0.1 which justifies the phrase "Use of salicylic acid has been considered to result in insignificant environmental risk."
Degradation
Biotic degradation
Ready biodegradability:
During 14 days, the biodegradation of salicylic acid at an initial concentration of 100 mg/L was followed. Inoculum used in the test was an activated sludge at a concentration of 30 mg/L obtained by mixing 10 different samples from different city and industrial sewage plants, soils and rivers in Japan. 3 parameters were followed: the Biological Oxygen Demand (BOD), the Total Organic Carbon (TOC) and the test substance analysis estimated by HPLC). The corresponding percentages of biodegradation obtained after 14 days were 88.1 %, 97.6 % and 100% respectively. Under the test conditions salicylic acid is therefore considered as readily biodegradable. (OECD 301C) (Ref III)
Abiotic degradation
Hydrolysis:
Not expected to undergo hydrolysis in the environment due to the lack of functional groups that hydrolyze under environmental conditions (Ref. V)
Justification of chosen degradation phrase:
Salicylic acid is readily biodegradable. The phrase “Salicylic acid is degraded in the environment” is thus chosen.
Bioaccumulation
Partitioning coefficient:
Log Kow = 2.26 (QSAR Method) (Ref. VI)
BCF = 3 (QSAR Method) (Ref VI)
Justification of chosen bioaccumulation phrase:
Since log Kow < 4 and BCF < 500, salicylic acid has low potential for bioaccumulation.
References
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Data from IQVIA ”Consumption assessment in kg for input to environmental classification - updated 2020 (data 2019)”.
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ECHA, European Chemicals Agency. 2008 Guidance on information requirements and chemical safety assessment. http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en.htm
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Kamaya, Y., Y. Fukaya, and K. Suzuki. Acute Toxicity of Benzoic Acids to the Crustacean Daphnia magna. Chemosphere 59(2):255-261., 2005.
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ECHA Registration Dossier for Salicylic Acid, https://echa.europa.eu/registration-dossier/-/registered-dossier/14544/6/2/7, accessed on 11/28/17
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Lyman WJ et al; Handbook of Chemical Property Estimation Methods. Washington, DC: Amer Chem Soc pp. 7-4, 7-5, 8-12. 1990.
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Hansch, C., Leo, A., D. Hoekman. Exploring QSAR - Hydrophobic, Electronic, and Steric Constants. Washington, DC: American Chemical Society., 1995., p. 29